Breast treatment device

ABSTRACT

The present disclosure provides devices for treating breasts. The devices ( 100 ) include a sheet of acellular tissue matrix having a predefined shape that allows for complete or enhanced coverage of an anterior portion of a breast implant or tissue expander or to support an implant and/or surrounding tissues. The sheet includes curved upper and lower borders or edges.

This application claims priority under 35 USC § 119 to U.S. ProvisionalApplication No. 62/381,865, which was filed on Aug. 31, 2016 and ishereby incorporated by reference in its entirety.

The present disclosure relates generally to devices for improving breastsurgeries, including tissue matrices specially shaped and sized forbreast reconstruction or augmentation.

The use of acellular tissue matrices such as ALLODERM®, a dermalacellular matrix produced by LIFECELL® CORPORATION (Branchburg, N.J.),for use in breast procedures has become increasingly popular withplastic surgeons. Such materials provide a number of advantages and canbe used to replace or augment supportive structures after, for example,mastectomy. Such materials can also be useful in reconstructive oraesthetic procedures (e.g., breast augmentation) by providing additionalsupport for breast implants, allowing improved control of breast shape,preventing skin rippling, and/or preventing or treating other problemsthat may occur with breast augmentation (e.g., symmastia and bottomingout.)

For many surgical procedures, in order to achieve desired results,surgeons must alter the shape of sheets of tissue matrices. However,correctly forming the necessary shapes and implanting the materialsproperly can be time consuming, especially for less experiencedsurgeons. Furthermore, tissue matrices such as acellular dermal matricescan be expensive. Accordingly, requiring surgeons to reshape or resizerelatively large pieces of such materials is not cost effective. Toimprove both surgical results and efficiency (in terms of both operativetime and cost), pre-sized or pre-shaped tissue matrices can bebeneficial. In addition, to provide coverage to select portions ofimplants or tissue matrices (e.g., the anterior surface orskin-contacting surface) improved, pre-formed shapes may be useful.Furthermore, matrices that are sized and shaped to facilitate completecoverage of the implant, complete coverage of selected parts (theanterior portion and/or parts of the superior/inferior/lateral/posteriorimplant), and/or attachment to surrounding structures can be useful. Inaddition, matrices sized and shaped to provide support to the breastand/or an implant, or to reinforce, augment, or otherwise protect orimprove the quality of the overlying dermal tissue in prepectoral orother breast reconstructive procedures is desired for some patients.

The present application provides improved breast treatment devicesincluding tissue matrix materials specially shaped and/or sized toimprove surgical breast procedures.

Accordingly, in some embodiments, a breast treatment device is provided.The device can include a sheet of acellular tissue matrix, wherein thesheet of acellular tissue matrix comprises a flexible sheet with a topsurface and a bottom surface, wherein the sheet has a first section anda second section, and the first and second sections have differentshapes and are attached to one another, and wherein the first sectionincludes curved first and second edges, and the second section includescurved first and second edges.

In some embodiments, a breast treatment device is provided. The devicecan include a sheet of acellular tissue matrix, wherein the sheet ofacellular tissue matrix comprises a flexible sheet with a top surfaceand a bottom surface, wherein the sheet has an upper curved borderhaving a first degree of curvature and a lower curved border having asecond degree of curvature, wherein the lower curved border is shapedand sized to conform to a desired shape of a lower margin of a breast,and wherein the upper curved border is sized and shaped such that theflexible sheet of acellular tissue matrix can cover substantially all ofthe anterior surface of a breast implant or tissue expander whenimplanted in a breast.

In some embodiments, a breast treatment device is provided. The devicecan include a sheet of acellular tissue matrix, wherein the sheet ofacellular tissue matrix comprises a flexible sheet with a top surfaceand a bottom surface, wherein the sheet comprises a lower curved borderand an upper curved border, wherein the upper curved border and lowercurved border are joined at apices at lateral ends of the device, andthe sheet is symmetrically shaped about an axis midway between theapices and parallel to the top and bottom surfaces when lying on a flatsurface, wherein the lower border forms a single outward arc shape, andwherein the upper border has three arc sections including first andsecond sections each extending from one of the apices, and a thirdsection joining the first and second sections, the third section havinga degree of curvature that is different than the degree of curvature ofthe first and section sections.

In some embodiments, a breast treatment device is provided. The devicecan include a sheet of acellular tissue matrix, wherein the sheet ofacellular tissue matrix comprises a flexible sheet with a top surfaceand a bottom surface, wherein the sheet has an upper curved borderhaving a first degree of curvature and a lower curved border having asecond degree of curvature, wherein the lower curved border is shapedand sized to conform to a desired shape of a lower margin of a breast,and wherein the sheet is sized and shaped to provide an interfacebetween subcutaneous tissue and the entire anterior surface of a breastimplant or tissue expander.

Also provided are methods of treatment that include implanting thedisclosed devices within a breast along with a breast implant or tissueexpander.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to exemplary embodiments, examples of whichare illustrated in the accompanying drawings. Wherever possible, thesame reference numbers will be used throughout the drawings to refer tothe same or like parts. The drawings are not necessarily to scale.

FIG. 1 illustrates a breast treatment device for more complete coverageof a breast implant or tissue expander in a pre-pectoral position,according to certain embodiments.

FIG. 2 illustrates a breast treatment device for more complete coverageof and/or support of a breast implant or tissue expander, according tocertain embodiments.

FIG. 3 illustrates another breast treatment device for more completecoverage of and/or support of a breast implant or tissue expander,according to certain embodiments.

FIG. 4 illustrates another breast treatment device for more completecoverage of and/or support of a breast implant or tissue expander,according to certain embodiments.

FIG. 5A is a frontal view of the breast treatment device including anacellular tissue matrix positioned over a breast implant to illustratehow the device provides coverage to the implant or tissue expander orsupports the implant or reinforces surrounding tissue.

FIG. 5B is a side view of the breast treatment device of FIG. 5Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander or supports the implant or reinforces surrounding tissue.

FIG. 5C is a top view of the breast treatment device of FIG. 5Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander or supports the implant or reinforces surrounding tissue.

FIG. 6A is a frontal view of a breast treatment device including anacellular tissue matrix positioned over a breast implant to illustratehow the device provides coverage to the implant or tissue expander.

FIG. 6B is a side view of the breast treatment device of FIG. 6Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander.

FIG. 6C is a top view of the breast treatment device of FIG. 6Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander.

FIG. 7A is a frontal view of a breast treatment device including anacellular tissue matrix positioned over a breast implant to illustratehow the device provides coverage to the implant or tissue expander.

FIG. 7B is a side view of the breast treatment device of FIG. 7Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander.

FIG. 7C is a top view of the breast treatment device of FIG. 7Aincluding an acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander.

FIG. 8A illustrates implantation of the breast treatment device of FIG.2 in a prepectoral position along with a breast implant.

FIG. 8B illustrates implantation of the breast treatment device of FIG.3 in a prepectoral position along with a breast implant.

FIG. 9 illustrates a breast treatment device for more complete coverageof a breast implant or tissue expander and/or support or reinforcementof surrounding tissues, wherein the device further includes preformedtabs or extensions for attachment to tissue, according to certainembodiments.

FIG. 10 illustrates a breast treatment device for more complete coverageof a breast implant or tissue expander and/or support or reinforcementof surrounding tissues, wherein the device further includes preformedslits or openings, according to certain embodiments.

FIG. 11 illustrates a breast treatment device for more complete coverageof a breast implant or tissue expander and/or support or reinforcementof surrounding tissues, wherein the device further includes preformedholes or openings, according to certain embodiments.

FIG. 12 illustrates a breast treatment device for more complete coverageof a breast implant or tissue expander and/or support or reinforcementof surrounding tissues, wherein the device further includes preformedholes or pilot holes, according to certain embodiments.

FIG. 13 illustrates a breast treatment device in accordance with theembodiments of FIG. 3 for more complete coverage of a breast implant ortissue expander and/or support or reinforcement of surrounding tissues,wherein the device further includes preformed holes or pilot holes,according to certain embodiments.

FIG. 14 illustrates another breast treatment device in accordance withthe embodiments of FIG. 3 for more complete coverage of a breast implantor tissue expander and/or support or reinforcement of surroundingtissues, wherein the device further includes preformed holes or pilotholes, according to certain embodiments.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to various embodiments of thedisclosed devices and methods, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including”, as well as other forms, such as “includes” and “included”,is not limiting. Any range described herein will be understood toinclude the endpoints and all values between the endpoints.

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.All documents, or portions of documents, cited in this application,including but not limited to patents, patent applications, articles,books, and treatises, are hereby expressly incorporated by reference intheir entirety for any purpose.

The present disclosure relates generally to devices for surgical breastprocedures and systems and methods relating to such devices. The devicescan be used for tissue augmentation, repair or regeneration of damagedtissue, and/or correction of tissue defects. As such, the devices,systems, and methods discussed herein can be suitable for a wide rangeof surgical applications, such as, for example, aesthetic surgery,breast reconstruction, breast augmentation, breast enhancement, breastreduction, and revisionary breast surgeries.

The tissue matrices used to produce the devices described herein caninclude a variety of different materials. For example, an acellulartissue matrix or other tissue product can be selected to allow tissueingrowth and remodeling to assist in regeneration of tissue normallyfound at the site where the matrix is implanted. For example, anacellular tissue matrix, when implanted on or into subdermal tissue,fascia, mammary tissue, muscle, bone, adipose or other tissue, may beselected to allow regeneration of the tissue without excessive fibrosisor scar formation. In certain embodiments, the devices can be formedfrom ALLODERM® or STRATTICE™ (LIFECELL® CORPORATION, BRANCHBURG, N.J.)which are human and porcine acellular dermal matrices, respectively.Alternatively, other suitable acellular tissue matrices can be used. Forexample, a number of suitable biological scaffold materials aredescribed by Badylak et al. “Extracellular Matrix as a BiologicalScaffold Material: Structure and Function,” Acta Biomaterialia (2008),doi:10.1016/j.actbio.2008.09.013. The devices described herein can beproduced from a variety of different human or animal tissues includinghuman, porcine, ovine, bovine, or other animals tissues.

Tissue matrix products, such as acellular dermal tissue matrices, arewidely used in surgical breast procedures. For example, sheets ofacellular dermal matrix can be provided as a square or rectangularsample, which can be cut to a desired shape if needed. In addition,certain preformed tissue matrix shapes are available. For example,crescent or other curved shapes are available to reduce the amount oftissue matrix needed while providing an appropriate shape for anaesthetically desirable surgical result.

For some surgical applications, however, different shapes and sizes fortissue matrices would be beneficial. For example, when implanting abreast implant or tissue expander in a pre-pectoral position, i.e.,anterior to the pectoral muscles, it would be beneficial in some casesto provide a tissue matrix shape and size that allows one or more of (1)complete or near complete anterior coverage of an implant or tissueexpander, (2) minimized need for resizing or shaping the tissue matrix,or (3) preshaped borders that facilitate attachment to anatomicalstructures to produce desired surgical results (e.g., aesthetic orreconstructive result with low likelihood of complications).

FIG. 1 illustrates a breast treatment device 100 for more completecoverage of a breast implant or tissue expander in a pre-pectoralposition and/or to support a breast implant or tissue expander, or helpregenerate, reinforce, augment, or support surrounding tissue such asoverlying dermis and subdermal tissue, according to certain embodiments.Although the devices and methods discussed herein are made with respectto, primarily, prepectoral procedures, the devices can be used bysurgeons for other procedures. The device 100 can include a flexiblesheet of acellular tissue matrix, as discussed above. As discussed inmore detail below, the device 100 can be affixed to a chest wall 30 orother appropriate tissue to cover an implant or tissue expander (notshown in FIG. 1). The device can be secured in place using sutures 60 orother surgical fixation devices (e.g., staples, clips, surgicaladhesives).

FIGS. 2-4 are top views of various embodiments of devices, according tothe present disclosure. The devices illustrated in FIGS. 2-4 can eachinclude flexible sheets of acellular tissue matrix, which can have oneof the illustrated shapes when laid flat. Each of the devices 100, 200,300, can allow complete or substantially complete coverage of theanterior portion of a breast implant or tissue expander, including animplant or tissue expander positioned anterior to the pectoralismuscles. In addition, or alternatively, the devices can help support abreast implant or tissue expander, or help regenerate, reinforce,augment, or support surrounding tissue such as overlying dermis andsubdermal tissue. When placed in contact with overlying tissue, thetissue matrix will support tissue regeneration, ultimately becominginfiltrated by cells and becoming vascularized, thereby providingenhanced tissue coverage to improve surgical outcomes, e.g., bypreventing various possible adverse events such as rippling, loss oftissue integrity.

FIG. 2 illustrates a breast treatment device 100 for more completecoverage of a breast implant or tissue expander and/or to support abreast implant or tissue expander, or help regenerate, reinforce,augment, or support surrounding tissue such as overlying dermis andsubdermal tissue, according to certain embodiments. As shown, the device100 includes a sheet of acellular tissue matrix. The sheet can include atop surface and a bottom surface (the surfaces correspond to the frontand back of the two-dimensional image of FIG. 2).

The sheet forming the device 100 has a first section 104 and a secondsection 108, and the first 104 and second 108 sections have differentshapes and are attached to one another at a joining section 110. Thefirst section includes curved first 106 and second edges 111, and thesecond section includes curved first 114 and second edges 112.

The curvature of the edges 106, 111, 114, 112 of the first 104 andsecond 108 sections can be varied to produce a desired shape. Forexample, in one embodiment the first edge 106 of the first section 104has a degree of curvature that is greater than a degree of curvature ofthe second edge 111 of the first section 104. In addition, the firstedge 114 of the second section 108 can have a degree of curvature thatis greater than a degree of curvature of the second edge 112 of thesecond section 108. As shown, the first edges 106, 114 of the sections104, 108 are the edges at opposite ends of the device 100.

The second edge 111 and second edge 112 will be understood to refer to acurved edge extending from opposite apices 117/117′, 119/119′ of thesections 104, 108 (i.e., edges along dashed lines 113, 115). But, asshown in FIG. 2, the sections 104 and 108 are joined at a joiningsection 110, such that the first section 104 and second section 108 areattached to one another along the second edges 111,112 of each of thefirst section 104 and second section 108. The joining section 110 maysimply be a continuation of a single sheet of acellular tissue matrixforming the device 100. As shown, the apices 117/117′, 119/119′ arepointed to form an acute angle, but the apices may alternatively becurved or rounded.

The device 100 is illustrated as having two-dimensional symmetry about aline or axis 120 passing midway through the tissue matrix 100 when thedevice lies flat. Variations in the shape may be made, or the device maybe made nearly or perfectly symmetric. Furthermore, the device 100,having first and second sections 104, 108 can more readily conform to animplant or expander shape, provide improved support to an implant orexpander, or provide complete overlying tissue contact by virtue ofspaces on the lateral sides of the joining section 110, i.e., betweenthe second edges 111, 112, where a gap is formed.

FIG. 3 illustrates another breast treatment device 200 for more completecoverage of a breast implant or tissue expander, according to certainembodiments. As shown, the device 200 includes a sheet of acellulartissue matrix, wherein the sheet of acellular tissue matrix comprises aflexible sheet 200 with a top surface and a bottom surface (the surfacescorrespond to the front and back of the two-dimensional image of FIG.3).

The sheet 200 can be sized and shaped to allow coverage of a breastimplant or tissue expander, provide improved support to an implant orexpander, or provide complete overlying tissue contact. As shown, thesheet 200 has an upper curved border 210 having a first degree ofcurvature and a lower curved border 220 having a second degree ofcurvature. The upper border 210 and lower border 220 can be joined atlateral apices 224, 228, which can include a sharp angle or rounderedges.

As with the device 100 of FIG. 2, the device 200 can be sized and shapedto allow coverage of a breast implant or tissue expander, particularlyfor coverage of an anterior portion of the implant or expander whenimplanted in a prepectoral position. In addition or alternatively, thedevice can provide improved support to an implant or expander, orprovide complete overlying tissue contact. In one embodiment, the lowercurved border 220 is shaped and sized to conform to a desired shape of alower margin of a breast, and the upper curved border 210 is sized andshape such that the flexible sheet of acellular tissue matrix can coversubstantially all of the anterior surface of a breast implant to tissueexpander

Many implants or expanders will have a shape and size such that theimplant volume at the lower pole is greater than that at the upper pole.The device 200 (as well as other devices described herein), allowscoverage and support of such implants with little or no additionalmanipulation by surgeons (e.g., no cutting to size and shape). As such,the devices 200 (and 100, 300) prevent waste of valuable tissue matrixmaterial, save substantial operating room time, and have preformedmargins that produce a desired configuration when implanted.

The size and shape of the devices 100, 200, 300 can be selected based ontypical implant or tissue expander (when fully expanded) shapes andvolumes. For example, for the device 200 of FIG. 3, the device caninclude a lower section 230 and upper section 240 and the height orlength of the lower and upper sections 230, 240 can be selected based onthe desired implant or expander size and shape as well as a the need foradditional material to cover tissue or affix the device to surroundingstructures. Exemplary, sizes can include, for example a height (from thebottom or lower border 220 to top of upper border 210) from 15-25 cm,and a width from apices 224, 228 of 15-30 cm. For example, a smalldevice may have a height of 15 cm and width of 17-18 cm; a medium devicea height of 18-19 cm and width of 21-22 cm; and a large device a heightof 20-21 cm and width of 23-24 cm; and an extra-large device a height of22-23 cm and width of 26-27 cm.

FIG. 4 illustrates another breast treatment device 300 for more completecoverage of a breast implant or tissue expander. The device 300 caninclude a sheet 300 of acellular tissue matrix, wherein the sheet ofacellular tissue matrix comprises a flexible sheet with a top surfaceand a bottom surface (the surfaces correspond to the front and back ofthe two-dimensional image of FIG. 4).

The sheet 300 can include a lower curved border 314 and an upper curvedborder 316, wherein the upper border 316 and lower border 314 are joinedat apices 308, 309 at lateral ends of the device 300. As with the otherdevices 100, 200, the apices 308, 309 can be sharp angles or can berounded.

The device 300 can have a configuration such that when lying on a flatsurface, the sheet 300 is symmetrically shaped about an axis 320 midwaybetween the apices 308, 309 and parallel to the top and bottom surfaces.

The device 300 can also be shaped such that the lower border 314 forms asingle outward arc shape (lower section 302), and the upper border 316has three arc sections 306, 306′, 307, including first and secondsections 306, 306′ each extending from one of the apices 308, 309, and athird section 307 joining the first and second sections 306, 306′, thethird section having a degree of curvature that is different than thedegree of curvature of the first and section 306, 306′ sections. The arcsections 306, 306′, 307 can form the upper portion or section 304, whilethe lower border 314 defines the lower section 302.

As discussed previously, the devices described herein can be used toallow coverage of a tissue expander or implant, including implants orexpanders positioned in a prepectoral position. In addition oralternatively, the device can provide improved support to an implant orexpander, or provide complete overlying tissue contact. As such, FIG. 5Aillustrates a frontal view of the breast treatment device 100 includingan acellular tissue matrix positioned over a breast implant toillustrate how the device provides coverage to the implant or tissueexpander. It will be understood that when implanted, and as discussedfurther below, the tissue matrix will contact overlying dermal orsubcutaneous tissue, as well as possible contact and connection withmuscle or other tissues, and the matrix can support the implant, allowingrowth of tissue, and provide tissue regeneration, support, andvascularization, in some cases for patients for whom insufficient tissueor insufficient tissue strength or vascularity would have been presentin the absence of the tissue matrix. As such, the tissue matrix allowsprepectoral positioning while avoiding other, often difficultprocedures.

FIGS. 5B and 5C are side and top views, respectively, of the device ofFIG. 5A. FIGS. 6A-6C provide comparable views of the device 200 of FIG.3 over an implant; and FIG. 7A. FIGS. 7A-7C provide comparable views ofthe device 300 of FIG. 4 over an implant. It should be noted that thefrontal view is described in reference to how the device and implantshould be viewed with respect to a patient if the implant covered by thedevices 100, 200, 300 were located on the anterior chest wall. So, forexample, FIG. 5A is referred to as a frontal view as it is a viewshowing the front of the device 100 when covering an implant (behind thedevice) as it would be viewed from the front of a patient in whom thedevice is implanted.

FIG. 8A illustrates implantation of the breast treatment device 100 ofFIG. 2 in a prepectoral position along with a breast implant. And FIG.8B illustrates implantation of the breast treatment device 200 of FIG. 3in a prepectoral position along with a breast implant. A similarimplantation process and configuration would be applicable to the otherdevices 300 or variations thereof described throughout. As shown, thedevices 100, 200 are implanted to cover an implant 20 or expander on ananterior portion of the chest wall 30. One section 108 (or upper andlower section of device 200) is positioned to cover a lower portion ofthe implant, while the other section 104 covers an upper portion of theimplant 20.

To secure the devices 100, 200 (or any other device described herein) inplace, parts of the device 100, 200, such as the lower border 114, 220and/or upper border 106, 210 can be affixed to tissue using sutures,clips, staples, adhesives, or other suitable surgical fixation systems.In some cases, the device 100, 200 (or device 300) can be sized toprovide an amount of tissue matrix that wraps around the posteriorportion of the implant or expander, e.g., at the lowermargin/inframammary fold and/or at the superior surface of the implantor expander. The devices may be sized to wrap between, for example, 1-3cm, 1-2 cm around the posterior portion of the implant or expander ateither or both of the inferior or superior portions of the implant orexpander.

In some cases, the implant or tissue expander includes suture tabs orother fixation components to allow the device 100, 200, or 300 to besecured to the implant or expander. In such cases, the device can bejoined to the expander or implant prior to or during implantation beforefinal positioning within an implant site. In cases where the device 100,200, 300 is sized to wrap partially around a posterior portion of theimplant or expander, the tabs or fixation devices can be posteriorlylocated so that the device can be secured to the posterior aspect of theimplant or expander, while the device is in contact with overlyingsubdermal tissues when implanted.

The devices described herein can further be modified to facilitatefixation to tissue for proper implantation. For example, the devices caninclude features that provide additional material for attachment toanchors such as sutures and/or can include features that guide proper oreasier placement of sutures or other anchors. In addition, oralternatively, the devices can include openings, slits, or holes thatprovide for one or more of improved drainage or fluid flow, bettercoverage of the implant or expander, or changes in mechanical properties(e.g., more flexibility due to presence of slits, holes, or othermechanical modifications). FIGS. 9-14 illustrate various modifieddevices, and although shown with respect to the device shape of FIGS. 2and 3 (FIGS. 13 and 14 illustrate embodiments of the device of FIG. 3,it will be understood that similar modifications can be used with theother described devices of FIG. 4.

FIG. 9 illustrates a breast treatment device 900, wherein the devicefurther includes preformed tabs 910 or extensions for attachment totissue, according to certain embodiments. The tabs or extensions 910 canprovide additional area for passing sutures or other anchors, or can bespecifically shaped to engage with fixations devices located on thesurface of an implant or expander. Although a finite and specific numberof tabs 910 is illustrated, additional or fewer tabs 910 may be used.

FIG. 10 illustrates a breast treatment device 1000, wherein the devicefurther includes preformed slits 1010 or openings, according to certainembodiments. The slits 1010 or openings can allow flow of fluid throughthe tissue matrix, thereby preventing certain complications (e.g.,seroma or inability to drain infectious fluids). In addition, the slits1010 can be shaped and sized to allow expansion or more flexiblecoverage of an implant or expander.

FIG. 11 illustrates a breast treatment device 1100, wherein the devicefurther includes preformed holes 1110 or openings, according to certainembodiments. Similar to the openings 1010 of FIG. 10, the holes 1110 canallow fluid to flow through the material. The openings 1110 and slits1010 can be arranged in number, size, and location based on a variety offactors.

FIG. 12 illustrates a breast treatment device 1200, wherein the devicefurther includes preformed holes or pilot holes (holes and pilot holesrepresented by any of 1210, 1220, or 1230), according to certainembodiments. The holes or pilot holes 1210 can be provided to alloweasier, more rapid, or better fixation. For example, the holes or pilotholes can be positioned in a row or locations that correspond to adesired spacing or positioning to provide secure fixation, e.g., alongthe lower border corresponding to the inframammary fold when implanted.The holes or pilot holes can pass completely through the device to allowpassage of sutures or other anchors, or can include a countersink ordivot formation to provide an area of less density or strength to alloweasy anchor passage.

The holes or pilot holes can be positioned on the lower section of thedevice (holes 1210, 1220) and/or upper section 1230 near edges. Inaddition, holes or pilot holes may be formed at other regions ifdesired. Further, the holes or pilot holes can be in two or more rows,as illustrated, to allow multiple points of fixation and/or to give thesurgeon some choice in selecting holes location.

Similar to FIG. 12, FIGS. 13 and 14 illustrate embodiments of the device200 of FIG. 3, but further including holes, openings, or pilot holes. Asshown in FIG. 13, the holes, openings, or pilot holes 2210 may belocalizes to a portion of the device, e.g., the lower section, therebyproviding openings only around the lower pole of the implant or tissueexpander. Alternatively, the holes, openings or pilot holes can bearranged in other patterns or throughout the surface of the device, asshown in FIG. 14.

The holes, openings, and pilot holes will generally be positioned and ofa number such that they do not cause an undesirable loss of strength orarea for cellular ingrowth. In addition, the holes, openings, or pilotholes may be a distance from the edges of the devices such that they donot overlap with areas where sutures may be placed, or alternatively,can be placed to provide preformed opening/pilot openings to guide wheresutures may be placed.

In some cases, the tissue matrices can be produced from materials thatinclude a basement membrane on at least one surface. For example, thedevices can be produced from an acellular dermal matrix, and either thetop surface or bottom surface can include an epithelial basementmembrane across the surface. When implanted next to a breast implant ortissue expander, the basement membrane covered surface may face towardsthe implant or tissue expander such that the surface not including abasement membrane faces overlying vascularized tissue.

Methods of treatment using the devices discussed herein as well asdevices produced for use in such methods are further contemplated aswithin the scope of the present inventions. The methods are illustratedand discussed above with respect to FIGS. 8A and 8B, and aspects of themethods are elaborated upon herein. The devices can be used forimproving various procedures, such as prepectoral implantation of animplant. In many cases, the method will first include performing aprocedure to remove tissue, e.g., for surgical oncology, and cantherefore, include mastectomy, lumpectomy, or variations on thoseprocedures. The methods and device may also be used for augmentationprocedures without, or in a separate procedure from mastectomy or otherprocedures (e.g., for staged reconstruction). When used for implantationfor augmentation, or in a subsequent procedure, a surgeon may first forma pocket or space in the subcutaneous region.

After performing a mastectomy or other procedure and ensuring a properspace for the implant or expander, a surgeon may then place the tissuematrix materials described herein within the space, and affix portionsof the tissue matrices to tissues such as the chest wall or muscle, asillustrated in FIGS. 8A and 8B. As an example, the tissue can be affixedto the superior medial and lateral edges of the pectoralis major and tofascial at the level of the inframammary fold. As such, the tissuematrix comes in contact with overlying tissue (e.g., dermis) and isprepared to provide support to the implant or expander and subsequentlyallow tissue ingrowth and vascularization of overlying tissue.

Next, and implant or expander can be placed within the pocket, andremaining edges of the tissue matrix are sutured or otherwise attachedto tissue to close the implant pocket, followed by closure of thesurgical site.

It will be appreciated that the tissue matrix may alternatively bewrapped around the implant or expander outside the body, and the entiredevice (e.g., implant/expander and tissue matrix) can then be placed inthe surgical site. Further, implants or expanders may include astructure for securing to the tissue matrix and/or chest wall or othertissue.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of this disclosure. Itis intended that the specification and examples be considered asexemplary only, with the true scope and spirit of the disclosed devicesand methods being indicated by the following claims.

1. A breast treatment device, comprising: a sheet of acellular tissuematrix, wherein the sheet of acellular tissue matrix comprises aflexible sheet with a top surface and a bottom surface, wherein thesheet has a first section and a second section, and the first and secondsections have different shapes and are attached to one another, andwherein the first section includes curved first and second edges, andthe second section includes curved first and second edges.
 2. The deviceof claim 1, wherein the first edge of the first section has a degree ofcurvature that is greater than a degree of curvature of the second edgeof the first section.
 3. The device of claim 1, wherein the first edgeof the second section has a degree of curvature that is greater than adegree of curvature of the second edge of the second section.
 4. Thedevice of claim 1, wherein the first section and second section areattached to one another along the second edge of each of the firstsection and second section.
 5. The device of claim 1, wherein the sheetof acellular tissue matrix comprises a dermal tissue matrix.
 6. Thedevice of claim 1, wherein the acellular tissue matrix is a porcinetissue matrix.
 7. The device of claim 1, wherein the acellular tissuematrix is a human tissue matrix.
 8. The device of claim 1, wherein thedevice further comprises a breast implant or tissue expander.
 9. Amethod of treatment, comprising: selecting a breast treatment devicecomprising a sheet of acellular tissue matrix, wherein the sheet ofacellular tissue matrix comprises a flexible sheet with a top surfaceand a bottom surface, wherein the sheet has an upper curved borderhaving a first degree of curvature and a lower curved border having asecond degree of curvature, wherein the lower curved border is shapedand sized to conform to a desired shape of a lower margin of a breast,and wherein the upper curved border is sized and shaped such that theflexible sheet of acellular tissue matrix can cover substantially all ofthe anterior surface of a breast implant or tissue expander whenimplanted in a breast; and implanting the breast treatment device alongwith a breast implant or a tissue expander within a breast. 10-27.(canceled)
 28. The method of claim 9, wherein the method comprisesimplanting the breast implant or tissue expander anterior to pectoralismuscles.
 29. The method of claim 9, wherein the sheet of acellulartissue matrix is positioned adjacent to the breast implant or tissueexpander to cover substantially all of an anterior surface of the breastimplant or tissue expander.
 30. The method of claim 9, furthercomprising securing a portion of the sheet of acellular tissue matrix totissue.
 31. The method of claim 30, wherein the sheet of acellulartissue matrix is secured to a portion of a chest wall.
 32. The method ofclaim 9, wherein the sheet of acellular tissue matrix comprises one of adermal tissue matrix, a porcine tissue matrix, or a human tissue matrix.33. A method of treatment, comprising: selecting a breast treatmentdevice comprising a sheet of acellular tissue matrix according to claim1; and implanting the breast treatment device along with a breastimplant or tissue expander within a breast.
 34. The method of claim 33,wherein the method comprises implanting the breast implant or tissueexpander anterior to pectoralis muscles.
 35. The method of claim 33,wherein the sheet of acellular tissue matrix is positioned adjacent tothe breast implant or tissue expander to cover substantially all of ananterior surface of the breast implant or tissue expander.
 36. Themethod of claim 33, further comprising securing a portion of the sheetof acellular tissue matrix to tissue.
 37. The method of claim 33,wherein the sheet of acellular tissue matrix is secured to a portion ofa chest wall.